[Translation] A single-center, randomized, open-label, single-dose, two-formulation, four-period, two-sequence, completely repeated crossover bioequivalence study of telmisartan and amlodipine tablets in healthy participants under fasting and fed conditions

主要研究目的：以江苏亚邦爱普森药业有限公司研制的替米沙坦氨氯地平片（规格：40 mg/5 mg）为受试制剂，按生物等效性研究的有关规定，与Boehringer Ingelheim International GmbH持证的替米沙坦氨氯地平片（参比制剂，商品名：Twynsta®，规格：40 mg/5 mg）对比在健康人体内的相对生物利用度，考察两制剂的人体生物等效性。次要研究目的：观察受试制剂和参比制剂在健康参与者中的安全性。

[Translation]

Main research purpose: Using Telmisartan Amlodipine Tablets (Specification: 40 mg/5 mg) developed by Jiangsu Yabang Epson Pharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of bioequivalence studies, the relative bioavailability in healthy humans was compared with Telmisartan Amlodipine Tablets (reference preparation, trade name: Twynsta®, specification: 40 mg/5 mg) certified by Boehringer Ingelheim International GmbH, and the human bioequivalence of the two preparations was investigated. Secondary research purpose: To observe the safety of the test preparation and the reference preparation in healthy participants.

Start Date18 Feb 2025

Sponsor / Collaborator

Jiangsu Yabang Epson Pharmaceutical Co Ltd.

CTR20244151

/ CompletedNot Applicable

替米沙坦氨氯地平片在中国成年健康受试者中的一项单中心、随机、开放、空腹和餐后、单次给药、两制剂、三序列、三周期交叉生物等效性研究

[Translation] A single-center, randomized, open-label, fasting and fed, single-dose, two-dose, three-sequence, three-period crossover bioequivalence study of telmisartan and amlodipine tablets in healthy Chinese adult subjects

主要研究目的：考察单次口服（空腹/餐后）受试制剂替米沙坦氨氯地平片（规格：80mg/5mg，海南赛立克药业有限公司生产，海南赛立克药业有限公司提供）与参比制剂替米沙坦氨氯地平片（Twynsta®，规格：80mg/5mg，Boehringer Ingelheim International GmbH持证，海南赛立克药业有限公司提供）在中国成年健康受试者体内的药代动力学特征，评价空腹与餐后状态下口服两种制剂的生物等效性。次要研究目的：评价受试制剂和参比制剂单次口服（空腹/餐后）在中国成年健康受试者中的安全性。

[Translation]

Main study objectives: To investigate the pharmacokinetic characteristics of the test preparation Telmisartan Amlodipine Tablets (Specifications: 80mg/5mg, produced by Hainan Selike Pharmaceutical Co., Ltd., provided by Hainan Selike Pharmaceutical Co., Ltd.) and the reference preparation Telmisartan Amlodipine Tablets (Twynsta®, Specifications: 80mg/5mg, certified by Boehringer Ingelheim International GmbH, provided by Hainan Selike Pharmaceutical Co., Ltd.) in healthy adult Chinese subjects, and to evaluate the bioequivalence of the two preparations in fasting and fed states. Secondary study objectives: To evaluate the safety of the test preparation and the reference preparation in healthy adult Chinese subjects after a single oral administration (fasting/fed).

Start Date30 Nov 2024

Sponsor / Collaborator

Hainan Selection Pharmaceutical Co. Ltd.

CTR20241713

/ CompletedNot Applicable

替米沙坦氨氯地平片(80mg/5mg)在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, four-period, completely repeated crossover bioequivalence study of telmisartan and amlodipine tablets (80 mg/5 mg) in Chinese healthy subjects under fasting and postprandial administration conditions

主要研究目的：按有关生物等效性试验的规定，选择Boehringer Ingelheim International GmbH为持证商的替米沙坦氨氯地平片（商品名：Twynsta，规格：80mg/5mg）为参比制剂，对吉林省德商药业股份有限公司生产和持证的受试制剂替米沙坦氨氯地平片（规格：80mg/5mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂替米沙坦氨氯地平片（规格：80mg/5mg）和参比制剂替米沙坦氨氯地平片（商品名：Twynsta，规格：80mg/5mg）的安全性。

[Translation]

Main purpose of study: According to the provisions of relevant bioequivalence test, Telmisartan Amlodipine Tablets (trade name: Twynsta, specification: 80mg/5mg) with Boehringer Ingelheim International GmbH as the licensee was selected as the reference preparation, and the test preparation Telmisartan Amlodipine Tablets (specification: 80mg/5mg) produced and licensed by Jilin Deshang Pharmaceutical Co., Ltd. was subjected to human bioequivalence test on fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary purpose of study: To observe the safety of oral administration of the test preparation Telmisartan Amlodipine Tablets (specification: 80mg/5mg) and the reference preparation Telmisartan Amlodipine Tablets (trade name: Twynsta, specification: 80mg/5mg) by healthy volunteers.

Start Date17 Jun 2024

Sponsor / Collaborator

Jilin Province Deshang Pharmaceutical Co., Ltd.

100 Clinical Results associated with Amlodipine Besylate/Telmisartan

100 Translational Medicine associated with Amlodipine Besylate/Telmisartan

100 Patents (Medical) associated with Amlodipine Besylate/Telmisartan

Literatures (Medical) associated with Amlodipine Besylate/Telmisartan

01 Feb 2025·JOURNAL OF PHARMACEUTICAL SCIENCES

The impact of volume of dissolution medium for biopredictive dissolution/permeation studies of enabling formulations: A comparison of two brands of telmisartan / amlodipine tablets

Article

Author: Brandl, Martin ; Milsmann, Johanna ; Bauer-Brandl, Annette ; Eriksen, Jonas Borregaard

For compendial dissolution testing of solid dosage forms, media volumes of 500 to 900 mL are used in apparatus I and II to ensure sink conditions. However, these volumes are considerably larger than those in the gastrointestinal tract. Thus, the experiments are not biomimetic and possibly not suitable for biopredictive dissolution testing. The present study investigates the influence of volumes of dissolution media in non-compendial dissolution/permeation settings. Dissolution/permeation studies of two commercial bilayer tablets (Twynsta® and Arrow) containing the active pharmaceutical ingredients telmisartan (40 mg) and amlodipine (10 mg) were evaluated using the MacroFlux tool with various biomimetic media mimicking fasted and fed states as well as biological variability ("biorelevant"). Particularly, the two-stage dissolution process of telmisartan from the tablets is interesting because the compound has a pH-dependent solubility, and 2-stage dissolution leads to supersaturation and precipitation upon pH shift. For telmisartan, lower dissolution volumes significantly induced precipitation, leading to lower permeation, while no precipitation was observed in the larger volume. The permeation of telmisartan was overly sensitive to both pH and micelle concentrations in the biomimetic media. Amlodipine showed complete dissolution under any conditions, which correlates with its known complete absorption in vivo. In conclusion, volumes of dissolution media (and their compositions) are key parameters and play a significant role for designing relevant biomimetic experiments used to predict the bioavailability of supersaturating systems.

01 Oct 2020·Journal of clinical hypertension (Greenwich, Conn.)Q3 · MEDICINE

Efficacy and safety of co‐administered telmisartan/amlodipine and rosuvastatin in subjects with hypertension and dyslipidemia

Q3 · MEDICINE

Article

Author: Cho, Jin‐Man ; Kim, Hyungseop ; Sung, Ki Chul ; Hwang, Jinyong ; Yoo, Byung Su ; Kim, Pum‐Joon ; Lee, Jae‐Hwan ; Shin, Jin Ho ; Lee, Sang Hyun ; Sung, Jung‐Hoon ; Ahn, Jeong‐Cheon ; Kim, Woo‐Shik ; Hong, Seung Pyo ; Chae, In‐Ho ; Kim, Ju Han ; Choi, So‐Yeon ; Kim, Hyo‐Soo ; Kim, Moo Hyun ; Hong, Soon Jun ; Kwon, Kihwan ; Lee, Kyounghoon ; Cho, Yoonhwa ; Jin, Xuan ; Rhee, Moo‐Yong ; Lee, Hana ; Han, Ki Hoon ; Park, Chang‐Gyu ; Lee, Han Cheol ; Cho, Eun Joo ; Seo, Jeong‐Sook ; Hyon, Min Su

Abstract:

Single risk factors, such as hypertension and dyslipidemia, can combine to exacerbate the development and severity of cardiovascular disease. Treatment goals may be more effectively achieved if multiple disease factors are targeted with combination treatment. We enrolled 202 patients who were randomly divided into the following three groups: telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg, telmisartan 80 mg + rosuvastatin 20 mg, and telmisartan/amlodipine 80/5 mg. The primary efficacy variables were changes from baseline in mean sitting systolic blood pressure (MSSBP) between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg at 8 weeks, and the percent changes from baseline in low‐density lipoprotein (LDL) cholesterol between telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg at 8 weeks. The secondary efficacy variables were changes in MSSBP, mean sitting diastolic blood pressure (MSDBP), LDL cholesterol and other lipid levels at 4 weeks and 8 weeks, as well as observed adverse events during follow‐up. There were no significant differences between the three groups in demographic characteristics and no significant difference among the three groups in terms of baseline characteristics for the validity evaluation variables. The mean overall treatment compliance in the three groups was, respectively, 98.42%, 96.68%, and 98.12%, indicating strong compliance for all patients. The Least‐Square (LS) mean (SE) for changes in MSSBP in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan 80 mg + rosuvastatin 20 mg) groups were −19.3 (2.68) mm Hg and −6.69 (2.76) mm Hg. The difference between the two groups was significant (−12.60 (2.77) mm Hg, 95% CI −18.06 to −7.14, P < .0001). The LS Mean for the percent changes from baseline in LDL cholesterol in the two (telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg and telmisartan/amlodipine 80/5 mg) groups were −52.45 (3.23) % and 2.68 (3.15) %. The difference between the two groups was significant (−55.13 (3.20) %, 95% CI −61.45 to −48.81, P < .0001). There were no adverse events leading to discontinuation or death. Combined administration of telmisartan/amlodipine 80/5 mg and rosuvastatin 20 mg for the treatment of hypertensive patients with dyslipidemia significantly reduces blood pressure and improves lipid control. ClinicalTrials.gov identifier: NCT03067688.

01 Apr 2019·Clinical therapeutics

Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia: A Phase III, Multicenter, Randomized, Double-blind Study

Article

Author: Rhee, Moo-Yong ; Yoo, Ki-Dong ; Cho, Sang-Kyoon ; Kim, Kye-Hoon ; Yoo, Byung-Su ; Park, Sang-Ho ; Kim, Woo-Sik ; Lee, Han-Cheol ; Kim, Tae-Seok ; Ahn, Jeong-Cheon ; Park, Dae-Gyun ; Kim, Seok-Yeon ; Cha, Dong-Hun ; Rha, Seung-Woon ; Oh, Yong-Seog ; Sung, Ki-Chul ; Yoon, Young-Won ; Yoon, Myung-Ho ; Kim, Yong-Jin ; Jeon, Dong-Woon

PURPOSE:

Dyslipidemia and hypertension increase the risk for cardiovascular disease. Combination therapy improves patient compliance. This study was conducted to compare the efficacy and tolerability of the combination therapies telmisartan/amlodipine + rosuvastatin, telmisartan/amlodipine, and telmisartan + rosuvastatin in patients with hypercholesterolemia and hypertension.

METHODS:

In this Phase III, multicenter, 8-week randomized, double-blind study, participants with hypertension and dyslipidemia (defined as a sitting systolic blood pressure [sitSBP] of ≥140 mm Hg, a low-density lipoprotein-cholesterol [LDL-C] level of ≤250 mg/dL, and a triglyceride level of ≤400 mg/dL) were screened. After a 4-week washout/run-in period involving therapeutic lifestyle changes and telmisartan 80 mg once a day, eligible patients had a sitSBP of ≥140 mm Hg and met the LDL-C level criteria according to the National Cholesterol Education Program Adult Treatment Panel III cardiovascular disease risk category. Patients were randomly assigned to 1 of 3 groups: (1) telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg (TAR group); (2) telmisartan/amlodipine 80/10 mg (TA group); or (3) telmisartan 80 mg + rosuvastatin 20 mg (TR group). The primary efficacy end points were the percentage changes from baseline in LDL-C in the TAR and TA groups and the mean changes in sitSBP in the TAR and TR groups at week 8 compared to baseline. Continuous variables were compared using the unpaired t test or the Wilcoxon rank sum model, and categorical variables were compared using the χ² or Fisher exact test. Tolerability was assessed based on adverse events found on physical examination including vital sign measurements, laboratory evaluations, and 12-lead ECG.

FINDINGS:

A total of 134 patients were enrolled. The least squares mean percentage changes in LDL-C at 8 weeks after administration of the drug compared to baseline were -51.9% (3.0%) in the TAR group and -3.2% (2.9%) in the TA group (P < 0.001). At 8 weeks after baseline, the least squares mean (SE) changes sitSBP were -28.3 (2.4) mm Hg in the TAR group and -10.7 (2.1) mm Hg in the TR group (P < 0.001). The prevalence rates of treatment-emergent adverse events were 15.0%, 25.0%, and 12.2% in the TAR, TA, and TR groups, respectively; those of adverse drug reactions were 15.0%, 22.7%, and 10.2%. None of the differences in rates were significant among 3 groups.

IMPLICATIONS:

Triple therapy with TAR can be an effective treatment in patients with dyslipidemia and hypertension. The TAR combination has value for hypertensive patients with hyperlipidemia in terms of convenience, tolerability, and efficacy. ClinicalTrials.gov identifier: NCT03566316.

News (Medical) associated with Amlodipine Besylate/Telmisartan

29 Aug 2025

·www.einpresswire.com

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

15 Jun 2017

·www.daiichisankyo.com

Daiichi Sankyo Launches New Generic Drugs through Its Daiichi Sankyo Espha Subsidiary

PDF (1,008KB)PDF For Immediate Release Company name: DAIICHI SANKYO COMPANY, LIMITED Representative: Sunao Manabe, Representative Director, President and COO (Code no.: 4568, First Section, Tokyo Stock Exchange) Please address inquiries to Noriaki Ishida, Executive Officer, Vice President, Corporate Communications Department Telephone: +81-3-6225-1126 http://www.daiichisankyo.com Tokyo, Japan (June 15, 2017) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that on June 16, 2017, its generics subsidiary, Daiichi Sankyo Espha Co., Ltd (hereinafter, Daiichi Sankyo Espha), will launch eleven new generic drugs with six new active ingredients, out of the seventeen new drugs and eight new active ingredients that have been announced through today’s official gazette. Overview of Newly Released Products 1. Product Names/Therapeutic Categories Products launched on June 16 (Authorized Generic products marked with an asterisk) Product name Therapeutic category Original brand name *Telmisartan Tablets 20mg “DSEP” Biliary excretion sustained release AT1 receptor antagonist MicardisⓇ Tablets 20mg/40mg/80mg *Telmisartan Tablets 40mg “DSEP” *Telmisartan Tablets 80mg “DSEP” *TeramuroⓇ Combination Tablets AP “DSEP” Biliary excretion sustained release AT1 receptor antagonist / Sustained release Ca antagonist combination MicamloⓇCombination Tablets AP/BP *TeramuroⓇ Combination Tablets BP “DSEP” *TelthiaⓇ Combination Tablets AP “DSEP” Biliary excretion sustained release AT1 receptor antagonist / Diuretic combination MicombiⓇCombination Tablets AP/BP *TelthiaⓇ Combination Tablets BP “DSEP” Entecavir Tablets 0.5mg “DSEP” Antiviral chemotherapeutic agent BaracludeⓇ Tablets 0.5mg Montelukast Chewable Tablets 5mg “DSEP”1 Leukotriene receptor antagonist/ Bronchial asthma treatment SingulairⓇ Chewable Tablets 5mg KIPRESⓇ Chewable Tablets 5mg Montelukast Powder 4mg “DSEP” 1 SingulairⓇPowder 4mg KIPRESⓇ Powder 4mg Folinate Tablets 25mg “DSEP” Reduced folic acid formulation UzelⓇ Tablets 25mg LeucovorinⓇ Tablets 25mg 1Montelukast Chewable Tablets 5mg “DSEP” and Montelukast Powder 4mg “DSEP” are new formulations of previously released active ingredients. Daiichi Sankyo Espha is the only company to have listed the following six new generic drugs and two new active ingredients in the National Health Insurance reimbursement price list. Daiichi Sankyo Espha will prepare diligently and launch the products and related information in mid-September. Products to be launched in mid-September (Authorized Generic products marked with an asterisk) Product name Therapeutic category Original brand name *Olmesartan OD Tablets 5mg “DSEP” High affinity AT1 receptor antagonist OlmetecⓇOD Tablets 5mg/10mg/20mg/40mg *Olmesartan OD Tablets 10mg “DSEP” *Olmesartan OD Tablets 20mg “DSEP” *Olmesartan OD Tablets 40mg “DSEP” *Rosuvastatin Tablets 2.5mg “DSEP” HMG-CoA reductase inhibitor CrestorⓇTablets 2.5mg/5mg *Rosuvastatin Tablets 5mg “DSEP” 2. Product Attributes (1) Innovative design of tablets Double-sided printing Information including product name and active ingredients are printed on both sides of the tablet using inkjet or stamp pad printing, as appropriate, making the tablets easy to identify. Other innovations The flavor and stability have been improved according to the individual characteristics of each formulation, in addition to which the shelf-lives of these products have been extended. (2) Innovative design of PTP sheets Continuing formulation and labeling innovations reduce the burden on pharmacists seeking to avoid mistakes with drugs and prevent medical errors such as a patient taking the wrong medicine. (A) Original, easily recognizable symbols PTP sheets with original symbols based on formulation and disease characteristics. (B) GS1 code for each tablet A GS1 DataBar barcode is displayed on the back of the PTP sheet to reduce the burden on pharmacists seeking to avoid mistakes when dispensing. GS1 DataBar Barcodes GS1 codes are a global standard adopted in 2010. DataBar barcodes are a GS1 code type that enables per sheet management of product name, content, volume and number of tablets. (C) Pitch control (fixed position printing) Facilitates identification of product name, active ingredient and the name “DSEP.” (D) Other innovations Montelukast Powder uses a rounded, easy-to-open stick package. (3) Innovative Box Design Some of the new products will be in “iPackage” boxes that make various types of information available for confirmation at the time of dispensing. About Daiichi Sankyo Espha Based on the spirit of the Daiichi Sankyo Group corporate mission* of supplying pharmaceuticals to address diverse medical needs, Daiichi Sankyo Espha provides innovative high value-added generic drugs characterized by ingenious formulations and labeling as well as authorized generic drugs, which are manufactured from the same substances and additives, with the same manufacturing methods, in the same plant as the original drugs. Daiichi Sankyo Espha strives to provide pharmaceuticals that offer users peace of mind by fulfilling the most important pharmaceutical criteria of quality, information, and stable supply while delivering the economic benefits of generic drugs. *Daiichi Sankyo Group corporate mission: To contribute to the enrichment of quality of life around the world through the creation of innovative pharmaceuticals and through the provision of pharmaceuticals addressing diverse medical needs. Daiichi Sankyo Espha Company Overview Company name: Daiichi Sankyo Espha Co., Ltd. Established: April 1, 2010 Business: Manufacture and sale of pharmaceuticals Capital: 450 million yen Representative: President Hiroto Yoshiwaka Headquarters: 3-5-1, Nihonbashi, Honcho, Chuo-ku, Tokyo Website: http://www.daiichisankyo-ep.co.jp/Open new window.

Drug Approval

15 Feb 2017

·www.daiichisankyo.com

Daiichi Sankyo Strengthens Authorized Generic Business through Daiichi Sankyo Espha

PDF (18KB)PDF For Immediate Release Company name: DAIICHI SANKYO COMPANY, LIMITED Representative: George Nakayama, Representative Director, President and CEO (Code no.: 4568, First Section, Tokyo Stock Exchange) Please address inquiries to Noriaki Ishida, Executive Officer, Vice President, Corporate Communications Department Telephone: +81-3-6225-1126 http://www.daiichisankyo.com Tokyo, Japan (February 15, 2017) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that its generics subsidiary, Daiichi Sankyo Espha Co., Ltd (hereinafter, Daiichi Sankyo Espha), plans to further strengthen its authorized generic (hereinafter, AG) business in Japan. 1. Daiichi Sankyo Espha AG Business Daiichi Sankyo Espha considers AGs to be “generic drugs that inherit trust accumulated in medical practice from the original brand drugs as an asset, and that contribute to patients and to medical practice itself.” In December 2014, Daiichi Sankyo Espha released an AG for Cravit® (generic name: levofloxacin) that was well-received in clinical practice. In the future and as medical needs increase, Daiichi Sankyo Espha expects AGs to become the standard for generics, and will aim to expand and penetrate AG products into the market, including Daiichi Sankyo origin products and from collaborations with other companies. 2. Products approved for manufacturing and marketing Today, Daiichi Sankyo Espha obtained approval for manufacturing and marketing for multiple AG products, including the following products: < Major AG products approved for manufacturing and marketing > Product name Original brand name Original brand manufacturer/distributor Olmesartan OD Tablets 5mg, 10mg, 20mg, 40mg “DSEP” Olmetec® OD Tablets Manufacturer: Daiichi Sankyo Co., Ltd. Telmisartan Tablets 20mg, 40mg, 80mg “DSEP” Micardis® Tablets Manufacturer: Nippon Boehringer Ingelheim Co., Ltd. Distributor: Astellas Pharma Inc. Teramuro® Combination Tablets AP, BP “DSEP” Micamlo® Combination Tablets Telthia® Combination Tablets AP, BP “DSEP” Micombi® Combination Tablets Rosuvastatin Tablets 2.5mg, 5mg “DSEP” Crestor® Tablets Manufacturer: AstraZeneca K.K. Distributor: AstraZeneca K.K., Shionogi & Co., Ltd. With respect to AG products approved for manufacturing and marketing this time, Daiichi Sankyo Espha plans to prepare for 2017 listings on the National Health Insurance drug price list as soon as a stable supply can be secured. About Daiichi Sankyo Espha Daiichi Sankyo Espha provides innovative high value-added generic drugs with formulation and devisal labeling as well as authorized generics which are manufactured from the same substances and additives that are manufactured in the same manufacturing methods in the same plant as original drugs based on the spirit of the Daiichi Sankyo Group corporate mission* of supplying pharmaceuticals to address diverse medical needs. Daiichi Sankyo Espha strives to provide pharmaceuticals that provide peace of mind for users by fulfilling the most important pharmaceutical criteria of quality, information, and stable supply while delivering the economic benefits of generics. *Daiichi Sankyo Group corporate mission: To contribute to the enrichment of quality of life around the world through the creation of innovative pharmaceuticals, and through the provision of pharmaceuticals addressing diverse medical needs. Daiichi Sankyo Espha Company Overview Company name: Daiichi Sankyo Espha Co., Ltd. Established: April 1, 2010 Business: Manufacture and sale of pharmaceuticals Capital: 450 million yen Representative: President Hiroto Yoshiwaka Headquarters: 3-5-1, Nihonbashi, Honcho, Chuo-ku, Tokyo

Drug Approval

100 Deals associated with Amlodipine Besylate/Telmisartan

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Essential Hypertension	European Union	Boehringer Ingelheim International GmbH	07 Oct 2010
Essential Hypertension	Iceland	Boehringer Ingelheim International GmbH	07 Oct 2010
Essential Hypertension	Liechtenstein	Boehringer Ingelheim International GmbH	07 Oct 2010
Essential Hypertension	Norway	Boehringer Ingelheim International GmbH	07 Oct 2010
Heart Failure	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	16 Oct 2009
Hypertension	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	16 Oct 2009
Myocardial Infarction	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	16 Oct 2009
Renal Insufficiency	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	16 Oct 2009
Stroke	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	16 Oct 2009
Vision Disorders	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	16 Oct 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Resistant hypertension	Phase 3	United States	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	Belgium	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	Canada	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	Denmark	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	Finland	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	France	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	Netherlands	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	Norway	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	Philippines	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	South Africa	Boehringer Ingelheim GmbH	01 Oct 2007

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03067688 (Pubmed \| J Clin Hypertens (Greenwich))	Phase 3	Dyslipidemias \| Hypertension	202	telmisartan/amlodipine 80/5 mg + rosuvastatin 20 mg	dxvxbxgbtl(cqfvkugbuq) = ouopyiijmm smijkubprs (spwbxvbauv ) View more	-	01 Oct 2020
				telmisartan 80 mg + rosuvastatin 20 mg	dxvxbxgbtl(cqfvkugbuq) = gmtxuulopc smijkubprs (spwbxvbauv )
NCT03566316 (Pubmed)	Phase 3	Hyperlipidemias \| Hypertension	134	telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg	midnpforwg(zausoiuogb) = qohhptqhef yvcbkjvjem (wrqeiblflr ) View more	-	01 Apr 2019
				telmisartan/amlodipine 80/10 mg	midnpforwg(zausoiuogb) = vxhrsalddo yvcbkjvjem (wrqeiblflr )
NCT02734355 (CTgov)	Phase 4	Atrial Fibrillation	64	Telmisartan 80 mg and amlodipine 5 mg (Therapy)	sxjnkgnedj(ajdahtqzjk) = hiveaxcfyr kmuiqumyex (tmmlrfkngh, 4.4) View more	-	22 Mar 2017
				Placebo (for telmisartan and amlodipine) (Placebo)	sxjnkgnedj(ajdahtqzjk) = gulhewuoan kmuiqumyex (tmmlrfkngh, 5.2) View more
NCT01975246 (CTgov)	Phase 3	Hypertension \| Essential Hypertension	309	Placebo+Telmisartan + amlodipine	vjutchqcux(ietwbtxorp) = lrabmietwh yrcojqkvax (wbpvxxhfia, 0.5) View more	-	29 Nov 2016
NCT01103960 (CTgov)	Phase 3	Hypertension \| Essential Hypertension	324	Amlodipine (A5 Alone)	puzrwlngbr(vhfjhcimik) = yhinogdqfw pwdrpqekbv (txacsztceu, 0.93) View more	-	20 Sep 2012
				Amlodipine+Telmisartan (T80/A5)	puzrwlngbr(vhfjhcimik) = gpllecyxnn pwdrpqekbv (txacsztceu, 0.95) View more
NCT01204398 (CTgov)	Phase 3	Hypertension	27	Amlodipine+Telmisartan	jxoofeikei(vlzhgizlvc) = knvncwpihx jbvvsncqgt (eobtmlfjwd, 7.42) View more	-	24 Aug 2012
NCT01134393 (CTgov)	Phase 3	Essential Hypertension	502	Amlodipine+Telmisartan (T80/A5)	dsundxwaxm = nwfvfvonbm kynkcdblly (csizsqxfzh, jcciijzzyg - goxuzzvoju) View more	-	04 Jul 2012
				Amlodipine+Telmisartan (T80/A10)	uxjmmietrx(ypczewpssn) = asjheowsup fqictqzrww (oacrbuzvqb, gmntbthcrn - fcyuqolsse) View more
NCT01222520 (CTgov)	Phase 3	Hypertension \| Essential Hypertension	174	Telmisartan and amlodipine	cggzvtlptq(uhjwuerish) = fxedmskcms dthisrhesq (jgrlninxlp, 0.73) View more	-	04 Jul 2012
NCT00860262 (CTgov)	Phase 3	Hypertension	858	Amlodipine+Telmisartan (T80+A10)	btsngoxhqm(vnlmmzxnwy) = yqiphnwlwc uemfdopeuk (szcnuuxvxs, 0.69) View more	-	04 Jan 2011
				Telmisartan (Telmisartan 80 mg)	btsngoxhqm(vnlmmzxnwy) = vdpczijhcy uemfdopeuk (szcnuuxvxs, 0.96) View more
TEAMSTA-10 (ESH2010)	Not Applicable	Hypertension	838	Telmisartan 40 mg/Amlodipine 10 mg	laocqdohzr(fierxuqsfd) = 1.9% (16/835) of patients discontinued trial treatment because of adverse events bfskduaccz (mswzkzlbpw ) View more	Positive	01 Jun 2010
				Amlodipine 10 mg

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